May 26 (Reuters) – Advisers to the U.S. Food and Drug Administration will discuss whether COVID-19 vaccines should be updated to target the latest circulating XFG subvariant for the 2026-27 immunization campaign, according to documents filed on Tuesday.
While COVID variants continue to be derived from the JN.1 virus variant, new subvariants such as NB.1.8.1 and XFG have emerged since May last year, the agency said.
Earlier this month, the World Health Organization recommended vaccine manufacturers to target the monovalent LP.8.1 strain or other currently circulating variants such as XFG or NB.1.8.1.
The FDA advisory panel is set to vote on the updated formulation for COVID shots on Thursday, roughly two weeks after the departure of commissioner Marty Makary. His tenure was marked by a series of contentious decisions, including stricter requirements for COVID vaccine use.
Makary, who also drew criticism for public clashes with drugmakers over reviews of potentially lifesaving drugs and vaccines, has been replaced by Deputy Commissioner for Food Kyle Diamantas in an acting capacity.
Vaccine chief Vinay Prasad, who shared Makary’s criticism of current U.S. COVID vaccine policies, also stepped down recently. Karim Mikhail was named the acting director of the FDA’s vaccines and biologics unit earlier this month.
For the 2025-26 season, the FDA had recommended that COVID shots target LP.8.1 – a subvariant of the JN.1 strain.
U.S. Centers for Disease Control and Prevention data showed the XFG subvariant was estimated to account for a majority of cases in the United States over a four-week period up to April 11.
Three COVID shots have been authorized for use in the U.S.: Moderna and Pfizer-BioNTech’s messenger-RNA-based vaccines, as well as Novavax’s protein-based shot that takes longer to manufacture.
Novavax licensed its COVID vaccine to French drugmaker Sanofi in 2024 in a deal worth at least $1.2 billion. Sanofi, along with Pfizer and Moderna, is set to make a presentation to the advisory committee.
The vaccine manufacturers have indicated that they are prepared to produce an XFG vaccine for the 2026-27 vaccination season, the FDA said.
(Reporting by Mariam Sunny in Bengaluru; Editing by Pooja Desai and Diti Pujara)
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